Tony Hagen is senior managing editor for The Center for Biosimilars®.
Teva Pharmaceuticals USA has filed suit in an attempt to use the expanded biologics licensure pathway as a way to hold back a potential competitor.
The multiple sclerosis drug Copaxone (glatiramer acetate) has seen steep erosion of market share in recent years, owing to generic competition, and maker Teva Pharmaceuticals USA is seeking to raise the bar to entry for further competition.
It has filed suit in US District Court hoping to force the FDA to reclassify the drug as a biologic under the Public Health Service Act (PHS), which in turn would force new generic competitors to have their drugs approved under the biologics license pathway.
The difference, Teva argues, is that with a biologics license application, the company would be able to engage a would-be rival over potential patent infringements much earlier in the process, before the competitor’s product actually got to market and began to eat further into Copaxone’s market share.
The blockbuster Copaxone is no longer the revenue engine for Teva it once was. North American sales of the product dropped 26% from the last quarter of 2018 to the comparable 2019 quarter ($356 million vs $264 million), a decline largely chalked up to generic competition.
In its suit, Teva said an unnamed company has given notice that it intends to apply to have a glatiramer acetate product approved through the abbreviated new drug application (ANDA) pathway under the Federal Food Drug and Cosmetic Act (FD&C Act)—the pathway under which Copaxone was originally approved.
This could enable the rival to get the product on market before Teva could bring suit for infringement, Teva argues. If the rival were forced to file a biosimilar approval application, it would have to enter a “patent dance” prior to launch, which could delay market entry by years.
FDA Shuns Teva’s Request for Biological Status
Teva contends that when, on March 23, 2020, the FDA converted the licensure for 96 drugs previously approved under the FD&C Act to biologics products licenses under the PSA, the FDA should have given Copaxone that new status also, but didn’t.
Until 2019, chemically synthesized polypeptides were excluded from the definition of biologics under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which meant Copaxone was excluded.
That’s no longer the case, and Teva argues the product now fully meets the FDA’s stated definition of a biologic. However, the company contends the FDA has ignored its pleas to reclassify the product, right up until March 23, when the BPCIA biologics pathway transition occurred, reclassifying many protein-based products under the PHS licensure protocols. Teva filed its suit the next day.
“Under the BPCIA’s transition mandate, FDA should have deemed the Copaxone [FD&C Act approval] to be a “license” under the PHS,” Teva wrote. “Even if chemically synthesized polypeptides were not categorically proteins, Copaxone met the length and specificity requirements set forth in FDA’s definition of protein.”
Teva and the rival company have been unable to come to terms over the exchange of information that might enable Teva to formulate and exert its legal position, according to the suit.
Meanwhile, the rival company has given notice that it will soon file an ANDA for its product under the FD&C Act and has asked Teva to withhold asserting its patent rights over the marketing of that drug.
Teva has declined that request and, to date, the companies have “not been able to negotiate the information exchange necessary to consider such a covenant,” Teva wrote.
“If that manufacturer files an ANDA, it will not be required to notify [Teva], and [Teva] will not be able to assert their process patents against that manufacturer based on the submission to FDA,” Teva wrote in its suit.
Teva contends that having to make a claim of actual infringement would lead to delay and higher cost than litigating a case of “artificial infringement,” such as that posed by a biosimilar application, which would involve no tangible damages because the litigation would occur prior to product launch.
Teva has demanded that the court declare that Copaxone is a biological product under the BPCIA and that it be added to the list of former FD&C Act products that will be deemed biological products under the PHS.